MEMORANDUM OF UNDERSTANDING. Between. The Medicines and Healthcare products Regulatory Agency (Clinical Practice Research Datalink Division) and

Transcription

1 MEMORANDUM OF UNDERSTANDING Between The Medicines and Healthcare products Regulatory Agency (Clinical Practice Research Datalink Division) and The Health and Social Care Information Centre

2 Version Control Version Date Description /02/12 Early draft for discussion /02/12 Update following HSCIC/CPRD discussion /02/12 Update after IG review at the HSCIC /02/12 Update following HSCIC/CPRD discussion /03/12 Update after internal HSCIC review and legal review /03/12 Update following HSCIC/CPRD discussion /3/12 Changes following HSCIC review /3/12 Changes from CPRD review /3/12 Agreed 1 st version CPRD & HSCIC MoU V 1.00 Page 2 of 21

3 CONTENTS Clause Page 1. Purpose Definitions and Interpretations Application of the Agreement Roles and Responsibilities Transition Information Governance Costs, Charges and Revenue Scheme Intellectual Property Rights (IPR) Liabilities Publicity Contacts Annex 1 Key Contacts Annex 2 Examples of Research and Non-Research Purposes CPRD & HSCIC MoU V 1.00 Page 3 of 21

4 THIS MEMORANDUM OF UNDERSTANDING is made on 2012 BETWEEN: (1) The Medicines and Healthcare products Regulatory Agency, Clinical Practice Research Datalink Division (CPRD ) and (2) The Health and Social Care Information Centre (HSCIC) CPRD and HSCIC are referred to in this Memorandum of Understanding collectively as the Parties, and each individually as a Party. 1. PURPOSE The CPRD provides data and related research services for health research purposes. It is a new service hosted in the Medicines and Healthcare products Regulatory Authority (MHRA). It brings together the Health Research Support Service established by the Research Capability Programme, which helps researchers to access and analyse a wide range of health-care and other relevant information, services and products to support their research projects, and the General Practice Research Database (GPRD) which is the world's largest computerised database of anonymised longitudinal medical records from primary care which provides data, research and other services as well as tools to support medical and public health research. The HSCIC is England s national source of information about health, public health and adult social care. It collects data from a range of health and care organisations and ensures that it is processed securely. It analyses and converts the data into information that is used by a growing number of people and organisations for a wide range of secondary purposes, such as policy development, planning and commissioning, service improvement, research, public accountability and transparency. The HSCIC functions, subject to the proposed Health Bill, include: (i) (ii) (iii) (iv) (v) A national repository for data across health, public health and adult social care, with lead responsibility for data collection and assuring the data quality of those returns; A secure data linkage service, providing anonymised patient level data; Development and assurance of national indicators; A national framework for data quality assurance with clear national and local responsibilities for data quality and with data quality metrics as an integral part of our dissemination and publication processes; Publication and dissemination of data, information, indicators and statistics; CPRD & HSCIC MoU V 1.00 Page 4 of 21

5 (d) The parties wish to work in collaboration to support research in health, public health and adult social care and the overall health and wealth agenda, to make best use of public funding, avoid duplication of public services and provide clarity in the marketplace. This document formalises the agreement between CPRD and HSCIC to work together in furtherance of the joint aims of the parties. It sets out the roles and responsibilities of both parties and the terms of the agreement. A separate Service Level Agreement (SLA) will cover the operation of services provided by and between the parties. 2. DEFINITIONS AND INTERPRETATIONS Anonymisation The process of removing person identifiable information from data to the extent that it is not possible to identify the person from the data. Confidential Information Data Data linkage De-identification De-identified Data Direct Identifiers All Personal Data (as defined in the Data Protection Act 1998 and the Statistics and Registration Services Act 2007) and any information, however it is conveyed, that relates to the business, affairs, developments, trade secrets, know-how, personnel, and suppliers of the Parties, including all Intellectual Property Rights, together with all information derived from any of the above, and any other information clearly designated as being confidential (whether or not it is marked "confidential") or which ought reasonably be considered to be confidential Data or information collected from health and social care services and other sources including derived values, indicators and statistics calculated from the data. A function whereby patient level data from different datasets are linked using patient identifiers. Any processing that reduces the likelihood that a dataset will identify individuals. For this agreement it means data without any direct identifiers. Name, address, widely-used unique person or record identifier (notably National Insurance Number, NHS Number, Hospital Number), telephone number, address, and any other data item that on its own could uniquely identify the individual. CPRD & HSCIC MoU V 1.00 Page 5 of 21

6 Intellectual Property Rights Inventions, copyright, patents, database right, trade marks, designs including source code, object code formulae and algorithms that are embedded, and confidential know-how and any similar rights anywhere in the world whether registered or not, including applications and the right to apply for all such rights; Pseudonymisation The process of replacing person identifiable information from data to the extent that it is not possible to identify the person from the data, but does allow linkage to other person level data similarly pseudonymised with the same identifying code. This is subject to the retention of an identifying code which enables the identity of the person to be restored for those with the requirement and authority to know the identity of the person. Research For work to be classified as Research within the terms of this agreement it must satisfy all of the following: use patient level information have the intent to answer a specific research question is intended to benefit public health and/or advance medical science. is undertaken using a structured methodology, set out in a protocol approved by both an appropriate ethics and scientific approval committee will be put in the public domain by peer reviewed or web based publication or provision of results to a Regulator Research Market Regulator Individuals or bodies performing work for the purpose of Research (as defined above). For the avoidance of doubt Research Market is distinct from Market Research the latter being defined as research around selling and promotion. Is a body authorised through law or by government to regulate services in health and social care or more general business operation such as health and safety or financial operations CPRD & HSCIC MoU V 1.00 Page 6 of 21

7 THE PARTIES AGREE AS FOLLOWS: 3. APPLICATION OF THE AGREEMENT 3.1 Legal Status of this MOU This MOU: (i) (ii) (iii) (iv) (v) (vi) (vii) seeks to outline the key principles of the collaboration arrangements agreed between the parties; and sets out the respective duties and obligations which have been and shall be agreed between the Parties; and is intended to be the sole point of reference in respect of the agreed arrangements, save that this MOU shall not supersede or replace any other written arrangements agreed between the Parties prior to the Commencement Date of a more general application to their wider dealings with each other; and is not intended to be contractually binding in a court of law nor to give rise to any other legally enforceable rights or obligations, nor does this document constitute an offer to purchase or to supply services or goods on the terms set out in this document or at all; and is for the benefit of the Parties and is not intended to benefit to, or be enforceable by, any third party; and shall be governed by, and construed in accordance with the laws of England and Wales; and includes a dispute resolution escalation process ultimately to the Secretary of State and not through law courts. 3.2 Commencement & Term The agreement will commence on the date of signature by both parties. Subject to clause 3.5, this agreement shall expire on 31 March 2017, unless terminated earlier in accordance with clause 3.5 below. The Parties may by mutual agreement agree to extend the term of this agreement beyond the date set out in clause Review The agreement will be reviewed by both parties on an annual basis to ensure it continues to be appropriate and fit for purpose. CPRD & HSCIC MoU V 1.00 Page 7 of 21

8 3.4 Variation Any changes to this Agreement or the Schedules or Annexes shall be agreed by the parties. No change to this Agreement shall be binding on either party unless made in writing and signed by duly authorised representatives of both parties. 3.5 Termination (d) (e) (f) (g) This agreement may be terminated by either party on 90 days notice to the other party. During the notice period, any information or services which either party has agreed to supply by the time notice is served, shall be supplied, insofar as they are capable of supply during the notice period. Each party agrees that no requests for additional services shall be made to the other party during any period of notice. Where services are supplied by one party and paid for by the other party, any costs incurred or committed to provide those services, whether completed or stopped as a result of termination, will be paid to the party supplying the services. Termination of this agreement shall be without prejudice to the rights of either Party which shall have accrued by reason of, or be subsisting at, the date of termination. If a Party fails to comply with any of its obligations under this MOU the other Party may notify them of the breach in writing ("Non Compliance Notice"). Any Non Compliance Notice shall set out the nature of the Party's breach and specify the period within which it must be remedied, to be no less than 14 days of receipt of the Non Compliance Notice. If the Party who receives the Non Compliance Notice does not remedy such failure, or agree a plan to remedy the failure within the timeframe specified in the Non Compliance Notice then the Party who served the Non Compliance Notice shall be entitled to: (i) initiate the dispute resolution procedure in Section 3.6. (ii) terminate this MOU once such dispute resolution procedure has been exhausted (subject to any express agreement reached between the Parties to the contrary) and if the source of the Non Compliance Notice has not been remedied. CPRD & HSCIC MoU V 1.00 Page 8 of 21

9 3.6 Dispute resolution Any issues with or breaches of this agreement, including any areas of uncertainty around the roles or work of either party should be raised to the relationship managers in each party who will endeavour to agree a resolution. In the event that the relationship managers cannot agree a resolution the following escalation route shall apply: (i) (ii) (iii) to the responsible directors for CPRD and HSCIC Data Linkage Services as identified in Annex 1; to the Chief Executive Officers of the MHRA and HSCIC; to the DH Sponsors for the parties and ultimately the Secretary of State; Disputes in relation to the purpose of a service request as being Research or Other will go the Independent Scientific Advisory Committee (ISAC) (run by CPRD to give approval for research work). IASC will recommend whether the service should be considered to be for Research or Other purpose The view of the ISAC will not be binding, and if the parties are still in dispute it should be resolved by the dispute resolution process above. 4. ROLES AND RESPONSIBILITIES 4.1 Roles in the marketplace The parties agree roles in the marketplace based on the purpose for which data, information and related services will be used, and roles in the provision of services where they will co-operate. As far as possible this should ensure that customers are clear who to go to for specific purposes and avoid duplication of effort, while maximising the value and benefit of the two organisations working together. 4.2 Research Market The Research Market (as defined in section 2) is the role of the CPRD. The CPRD will provide the customer facing role for all data, information and supporting services. Where customers come to the HSCIC for services for research purposes, HSCIC will refer those customers to CPRD and all other suppliers known to the HSCIC. HSCIC agrees not to operate in this market, with the exception of the following services. HSCIC will continue to market and provide the functions of their Medical Research Information Services. These services cover: (i) Current status of identified cohorts (i.e. fact of death, demographics, registration with a GP, exit from the NHS); CPRD & HSCIC MoU V 1.00 Page 9 of 21

10 (d) (e) (ii) (iii) (iv) (v) Long term follow up of identified cohorts providing notification and details of mortality, morbidity particularly cancer and exit and re-entry to the NHS; List Cleaning, providing updates to patient demographics and death status; Assistance with the formal application process for cohort management; Processing of the ONS Longitudinal Study HSCIC may supply unlinked, de-identified data, direct to organisations in the research market if approached directly by them; or standard data extracts, linked and unlinked with pseudonymised identifiers direct to organisations in the research market if approached directly by them. For the avoidance of doubt this includes but is not limited to HES data, HES- PROMS and HES-ONS data.. HSCIC reserves the right to provide services including data linkage to other organisations which provide services to customers for the purposes of research. 4.3 Non-Research Market (d) (e) All other markets other than research as above will be the role of the HSCIC. The HSCIC will provide the customer facing role for all data, information and supporting services. This will include but not be restricted to all products and services in the HSCIC business plan. CPRD agrees not to operate in this market. Where Customers come to the CPRD for services for non-research purposes, CPRD will refer those customers to HSCIC. The same organisations may use services in both research and nonresearch markets, and it is the purpose which defines the market role and not the nature of the organisation. Annex 2 provides examples of research and non-research purposes to help to clarify the distinction and set out agreed understanding. Where the purpose may not be clear, the parties will notify each other and endeavour to agree a resolution. 4.4 Working in collaboration CPRD and HSCIC shall co-operate in furtherance of shared aims where the parties deem it appropriate to do so, but nothing in this agreement shall compel either party to collaborate solely or exclusively with the other party except where stated in this agreement. CPRD & HSCIC MoU V 1.00 Page 10 of 21

11 (d) (e) The parties agree to co-operate on the supply of linked data to the research market. HSCIC will provide all data linkage for CPRD under a separate SLA, which will specify the scope of work, costs and service levels. Where CPRD or their research customers require data, except for GPRD data or data already held by CPRD research customers, they shall contact the HSCIC in the first instance to obtain the data. The HSCIC will supply the data where practical to do so, but will agree to the CPRD obtaining the data directly where it is not practical or would cause a significant delay CPRD will act as the informed customer to HSCIC for the research market, providing feedback on data and services provided through CPRD and helping to ensure both parties products and services are fit for purpose and continuously improved. Both parties will share information and updates on circumstances and developments to keep the other party fully informed and able to work most effectively for the partnership. Information and updates relating to all work and potential work done in collaboration will be shared as matters arise and on a frequent regular basis through regular meetings at intervals agreed by the relationship managers of both parties. This will include: (i) (ii) (iii) (iv) review of provision of services; developments in the research market and possibilities for new linkages or other data services; developments in data and information services and any new data becoming available; report on the customers of CPRD and their data supply so the HSCIC is aware of the scale and scope of the Research Market and what data is being supplied to which customers. This will be in the form of an aggregate report split by user types rather than details of each study owner. 5. TRANSITION Transition arrangements will be required with the commencement of this agreement. Both parties will notify each other of work in progress which would otherwise come under this agreement. Work in progress will be transitioned to fit with the roles and responsibilities as set out in this agreement where it is practical and reasonable to do so based on the scale and longevity of the work. The parties will work together to agree transition plans. CPRD & HSCIC MoU V 1.00 Page 11 of 21

12 6. INFORMATION GOVERNANCE 6.1 Research and Data Access Approvals It will be the responsibility of CPRD and its customers to gain and present the required approvals, before HSCIC can perform and provide services. These approvals will include scientific approval, National Information Governance Board or its sub-committee s approval, Ethics Committee approval, or patient consent. 6.2 Data re-use & sharing agreements (d) HSCIC will put in place re-use and data sharing agreements to cover the data or services provided to CPRD. CPRD will in turn put in place re-use and data sharing agreements with it s customers receiving any data from CPRD via HSCIC which reflect the reuse and data sharing agreements with HSCIC. HSCIC will have the right to audit, review and enforce changes in CPRD re-use and data sharing agreements to ensure they meet HSCIC s needs. CPRD shall provide to HSCIC on a regular basis to be agreed by the relationship managers, a schedule of data sharing agreements to include the identity of the user organisation and the data included. Where possible re-use and data sharing agreements will restrict the use of the data to the purpose for which it was supplied and to the scope of the role of each party supplying the data. In the event that HSCIC has reason to believe a breach of a data re-use or sharing agreement has occurred with a CPRD customer, HSCIC has the right to compel CPRD to audit the customer. 6.3 Standard Code of Practice Users of HSCIC supplied data will need to abide by the Terms and Conditions or Re-Use agreements for the data, and these are likely to be re-iterated by a new Code of Practice for the collection, analysis, and handling of confidential information for secondary uses. This Code of Practice will be published by the HSCIC as part of our duties under the Health and Social Care Bill (subject to Royal assent of the Bill). 6.4 Branding, Copyright and Representation Any HSCIC requirements, including those passed on by HSCIC, to show copyright or other acknowledgement statements with data and information when published must be reflected in CPRD agreements with it s customers. CPRD & HSCIC MoU V 1.00 Page 12 of 21

13 For HSCIC data, CPRD and their customers must acknowledge the source and HSCIC copyright in all publications or re-use of the data by including; Copyright (insert year), Re-used with the permission of The Health and Social Care Information Centre. All rights reserved." 6.5 Security & Data Protection Each party undertakes the following: Whenever processing any confidential and sensitive information that is the subject of the release or disclosure, each party will comply fully and in all aspects with the provisions of The Data Protection Act 1998 and all other relevant legislation (including any amendment or re-enactment thereof): in summary, each party must therefore, as minimum, ensure that: (i) (ii) (iii) (iv) (v) (vi) All confidential and sensitive information is processed fairly and lawfully; All confidential and sensitive information is obtained only for one or more specified and lawful purposes, and is not further processed in any manner incompatible with that purpose or those purposes; All confidential and sensitive information is adequate, relevant and not excessive in relation to the purpose or purposes for which it is processed; All confidential and sensitive information is accurate and, where necessary, kept up-to-date; No confidential and sensitive information is kept for longer than necessary for the purpose for which is was obtained; Appropriate technical and organisational measures are taken against unauthorised or unlawful processing of confidential and sensitive information and against accidental loss or destruction of, or damage to, confidential and sensitive information. 6.6 Confidentiality Each Party shall at all times keep confidential (and procure that its employees, sub-contractors and agents shall keep confidential) any information which is marked as confidential or stated to be confidential by the other Party or which would otherwise reasonably be anticipated to be confidential in nature, which is not in the public domain, which it or they may acquire during the course of this agreement in relation to the business and affairs of the other Party, and shall not disclose such information except with the consent of the other Party, or where expressly ordered to do so by a court of competent jurisdiction, or under any governmental request, law or regulation, or where such disclosure may otherwise be lawful. CPRD & HSCIC MoU V 1.00 Page 13 of 21

14 (d) (e) Each party shall not make any use of, or otherwise process, the Confidential Information received other than for the strict purpose or purposes which have been expressly agreed. Each party shall restrict access to the Confidential Information received solely to its responsible staff members and/or to the responsible staff members of any authorised third party organisation(s) who need to have such access for the strict purpose or purposes which have been expressly agreed. The obligations of each of the Parties contained in this clause shall continue in perpetuity, save that they shall cease to apply to any such information which comes into the public domain otherwise than by a breach by either Party of its obligations under this clause. Any breach of confidentiality by either party shall be notified to the other party immediately where possible, and not later than within two working days of any such breach becoming known. The communication of any such incidents with any third party will be handled by mutual agreement between the parties. 6.7 FOI Requests The parties acknowledge that both are subject to the requirements of the Freedom of Information Act (FOIA). Both parties agree to assist and cooperate with the other to enable each to comply with any information disclosure requirements. Where either party receives a request (the receiving party) to release any information that, under this Agreement, is the other party s (disclosing party s) Confidential Information, it will notify the disclosing party. The disclosing party shall respond to the receiving party within 5 working days of receiving the receiving party s notice of the request. In the event that the disclosing party fails to respond within the requisite period, the receiving party reserves the right to release any such information it deems appropriate. The receiving party shall be responsible for determining whether the information is:- (d) (i) (ii) exempt from disclosure in accordance with the FOIA; to be disclosed in response to a request for information under the FOIA and in no event shall the disclosing party respond directly to a request for information unless expressly authorised to do so by the receiving party. Notwithstanding the above clause 6.6, the parties agree that a receiving party shall not release any information without first seeking and giving full consideration to the views of the disclosing party in accordance with clause 6.6. CPRD & HSCIC MoU V 1.00 Page 14 of 21

15 7. COSTS, CHARGES AND REVENUE SCHEME 7.1 Normal operating charges Where data is provided between the parties or to third parties each party shall be entitled to charge its normal charges for the data and/or services supplied. Data linkage service costs will be specified as part of the separate Service Level Agreement for these services. 7.2 Revenue Scheme In exchange for the HSCIC agreeing that the Research Market, as defined in Section 2, is the role of the CPRD and that the HSCIC will not operate in this market, a revenue scheme based on the re-use of HSCIC supplied data for the research market will be operated such that growth in the market arising from the availability of a wider range of higher quality linked data benefits both parties appropriately. The scheme will provide revenue to the HSCIC as a transaction fee to directly reflect the re-use of HSCIC supplied data in the research market via CPRD. The details will be agreed by both parties and added to this agreement or the SLA for services to CPRD within 6 months. 8. INTELLECTUAL PROPERTY RIGHTS (IPR) Neither party shall acquire any right, title or interest in or to the IPR of the other party or its licensors unless agreed in writing. The IPR for any developments relating to the services developed, performed and used under this agreement will reside with the party developing or performing the work unless otherwise agreed in writing. For the avoidance of doubt the IPR for all designs, algorithms and knowhow relating to data linkage and any other data processing performed by the HSCIC shall be the property of the HSCIC. 9. LIABILITIES Neither party shall accept any liability for any errors, omissions or inaccuracies in the contents of the Data as received by the parties from each other, nor do they warrant that any such errors, omissions or inaccuracies will be corrected; and Neither party shall be held responsible for the suitability of the Data or the Services for any use to which they may be put by the other party. CPRD & HSCIC MoU V 1.00 Page 15 of 21

16 (d) (e) (f) Notwithstanding the above the Parties shall use reasonable endeavours to ensure that the data and services they provide are appropriate to their use. Subject to clause 9(e) the parties shall not be liable under this agreement for direct, indirect or consequential loss or damage, or financial losses, loss of contracts or opportunity, loss of operation time, loss of data, wasted management time, damage to goodwill, or loss or damage claimed by any third parties, arising out of or in connection with the use of the other party Data. Notwithstanding the above, the liability of each Party to the other for death or personal injury resulting from its own negligence shall not be limited. Each party will use its best endeavours to ensure that it owns or has sufficient licences to supply to the other party all data and materials it supplies under this Agreement. The parties acknowledge that where either of them have been granted a licence from a third party, their ability to permit the use or transfer of data in accordance with this MoU may be restricted, and they will make any restrictions clear to the other party in writing. 10. PUBLICITY Matters related to this agreement shall only be publicised with the agreement of both parties, which will not be unreasonably withheld. 11. CONTACTS 11.1 Key Contacts Each party will nominate a Relationship Manager for overseeing the operation of the agreement and related services. The parties will notify each other as soon as possible if the key contact changes. The Relationship Managers and other key contacts will be listed in Annex 1 CPRD & HSCIC MoU V 1.00 Page 16 of 21

17 EXECUTED BY THE PARTIES: Signed on behalf of The Medicines and Healthcare products Regulatory Agency (CPRD Division) by its duly authorised officer: Name: Date: Signed on behalf of The Health and Social Care Information Centre by its duly authorised officer: Name;: Date: CPRD & HSCIC MoU V 1.00 Page 17 of 21

18 ANNEX 1 KEY CONTACTS Main point of contact for the relationship between the organisations HSCIC Martin Orton Head of Customer and Account Services martin.orton@ic.nhs.uk Tel: CPRD Jon Ford CPRD Head of Operations Tel: Responsible Directors HSCIC Clare Sanderson Director of Information Governance clare.sanderson@ic.nhs.uk Tel: CPRD John Parkinson CPRD Director john.parkinson@mhra.gsi.gov.uk Tel: CPRD & HSCIC MoU V 1.00 Page 18 of 21

19 ANNEX 2 EXAMPLES OF RESEARCH AND NON-RESEARCH PURPOSES The examples below are set out to clarify the definition and interpretation of research used in this MoU. Examples where the purpose is agreed as Research as defined in this MoU. 1. A hypothesis testing cohort study into liver toxicity caused by (X drug) in patients with (Y condition). Protocol controlled study. The study will require primary care data sourced from the CPRD Division linked on an individual patient level to the national liver disease registry, ONS Mortality data and to HES inpatient data. 2. Carrying out a case-crossover study into the use of a particular class of drugs in pregnancy, and the outcomes on child health. Protocol controlled study. The study will require primary care data sourced from the CPRD Division linked on an individual patient level to HES inpatient data. 3. Undertaking a data mining analysis to assess specified adverse side effects from a medicine or class of medicines where this is controlled by a research protocol. 4. A study to investigate the associations between specific mental disorders in secondary mental health care (schizophrenia, schizoaffective disorder, bipolar disorder and dementia) and physical illness. This would use a new linked dataset containing health records for patients with these disorders from the trust s Case Register Interactive Search (CRIS) and general hospital records from the English national Hospital Episode Statistics (HES) database. 5. A cohort study of oncology patients into global health measures and toxicity to chemotherapy. The study will aim to document co morbidity scores from 3 separate sources: Medical notes, GP summary data and HES data. The existing ethical approval and consent forms allow for further analysis of the sort planned. In order to assess co morbidity scores on HES data of primary and secondary diagnoses (co morbidity), I need to make a request for patient identifiable data for this cohort of patients (likely to be 420 patients by end of recruitment in April). Examples where the purpose is agreed as not being Research as defined in this MoU. 6. Undertaking feasibility analysis to assess areas in which subsequent research may be undertaken. 7. Calculating regional disparities in use of (drug x) so that a marketing plan can be developed. 8. Undertaking an audit of national data to calculate the proportion of the population diagnosed with a particular condition or being prescribed a particular medicine. CPRD & HSCIC MoU V 1.00 Page 19 of 21

20 9. HES data used to check the completeness of data submissions of acute coronary syndromes to the national clinical audit (MINAP). 10. Identifying cohorts for analysis from health and social care data. 11. Surveillance of for example health of a population living in an area close to a nuclear power station. 12. Investigating drug use versus prevalence of health conditions in regions or areas without being controlled by a research protocol. 13. Monitoring uptake of new medicines or treatment methods from health and social care data without being controlled by a research protocol. 14. Investigating outcomes for patients to look at quality of services and support better commissioning 15. HES information will be linked to data collected as part of the English Longitudinal Study of Ageing (ELSA) and the Health Survey for England (HSE). The HSE is a cross-sectional study that comprises annual surveys designed to measure health and health related behaviours in a representative sample of adults and children in England. The survey includes a health interview and a health examination element. Core topics each year include general health, fruit and vegetable consumption, smoking and drinking, and objective measures include height and weight measurements, blood pressure and samples of blood, saliva and urine. In addition each year has an additional focus, such as cardiovascular disease, physical activity or respiratory conditions and lung functions. Linkage to HES data provides an important longitudinal element to the cross-sectional information, and can help to establish how risk factors, or combinations of risk factors, are associated with later hospital attendance and mortality. The HES data will be matched by serial number to anonymised HSE survey data records, and used for analyses of health conditions, outcomes, measurements or behaviours to provide aggregated results for the population or for key groups of the population. Great vigilance will be exercised at all times to ensure that no data outputs are disclosive or relate to very small groups of survey participants). 16. EMPES - The purpose of the EMPES is to continuously survey patients about their experience of a recent hospital episode. The analysis of the resultant data will be used to influence and guide commissioning decisions within the region and in turn improve both patient experience and care outcomes derived from SUS and PROMs data. The system will allow PCTs and Providers and to link the patient experience survey data to patients clinical outcomes. Patient experience data will be linked to the PROMs data using the NHS Number. This will the enable analysis where by the experience of a patient can be collated with the clinical outcome (PROMs). The overarching goal of the EMPES is to improve the quality of patient healthcare in the East Midlands region. The EMPES supports the Department of Health s Quality, Innovation, Productivity and Prevention (QIPP) agenda as well as other key initiatives outlined below through the benefits listed: CPRD & HSCIC MoU V 1.00 Page 20 of 21

21 Benchmarked patient experiences across the East Midlands organisations (PCTs or Trusts) between themselves, peer groups and against national patient experience information. This will highlight areas of good practice and where improvements to patient care can be made. Understanding the link between patient experience and clinical outcomes and monitoring trends in both to drive both commissioning and clinical behaviours. Information about experience and care will also be made available to patients and the public via online dashboards to help inform their choices Monitoring the performance of providers delivering healthcare from the perspective of the patient. In summary, EMPES allows greater understanding of care and services for patients as well as allowing both commissioners and providers to make informed decisions that will positively influence the delivery of services and improve patient experience. CPRD & HSCIC MoU V 1.00 Page 21 of 21